CompletedNot Applicable

Prospective Observational Study on the Effectiveness of Daridorexant in Chronic Insomnia in a Real-World Setting

Italy31 participantsStarted 2023-10-01

Plain-language summary

The primary objectives of this study is to evaluate the real-world effectiveness of daridorexant 50 mg in improving both subjective (self-report) and objective (actigraphic) sleep parameters in patients with chronic insomnia. The secondary aims of this study are: * To compare the effectiveness of daridorexant 50 mg with other guideline-recommended therapies for chronic insomnia in improving sleep parameters and sleep health. * To identify clinical and demographic predictors of response to daridorexant 50 mg, such as age, sex, BMI, duration of insomnia, and treatment regimen (monotherapy vs. add-on). * To monitor changes over time in the symptoms related to comorbid sleep disorders (e.g., OSA, RLS, circadian rhythm disorders) in patients treated with daridorexant 50 mg.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age ≥ 18 years * Signed informed consent form * Diagnosis of chronic insomnia according to DSM-5 criteria, defined as: Dissatisfaction with sleep quantity or quality, associated with one or more of the following: Difficulty initiating sleep Difficulty maintaining sleep (frequent awakenings or trouble returning to sleep) Early morning awakenings with inability to return to sleep The sleep disturbance causes clinically significant distress or impairment in social, occupational, educational, academic, or other important areas of functioning Sleep difficulties occur despite adequate opportunity and circumstances for sleep The insomnia is not better explained by or occurring exclusively during other sleep-wake disorders (e.g., narcolepsy, parasomnias, circadian rhythm sleep-wake disorders, breathing-related sleep disorders) The insomnia is not attributable to the physiological effects of a substance (e.g., drug abuse or medication) \- No contraindications to daridorexant use according to the European Medicines Agency (EMA) Exclusion Criteria: * Pregnancy * Breastfeeding * Withdrawal of informed consent at any time

What they're measuring

Change in total sleep time after 3 months of daridorexant treatment

Timeframe: From baseline (Day 0) to 3 months after treatment initiation

Change in wake after sleep onset after 3 months of daridorexant treatment

Timeframe: From baseline (Day 0) to 3 months after treatment initiation

Change in sleep efficiency after 3 months of daridorexant treatment

Timeframe: From baseline (Day 0) to 3 months after treatment initiation

Change in sleep regularity index after 3 months of daridorexant treatment

Timeframe: From baseline (Day 0) to 3 months after treatment initiation

Change in self-reported sleep questionnaires after 3 months of daridorexant treatment

Timeframe: From baseline (Day 0) to 3 months after treatment initiation

Trial details

NCT IDNCT07132086

SponsorAzienda Ospedaliero, Universitaria Pisana

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-03-01

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